Global, biopharmaceutical company at the forefront of designing precision combinations in the pursuit of cures
Senior Director - PV Science, Patient Safety & Pharmacovigilance
Location
United States
Posted
2 days ago
Salary
$285K - $295K / year
Seniority
Lead
No structured requirement data.
Job Description
- Manage a team of PV scientists
- Interact with cross-functional leaders for establishing process improvement as necessary
- Provide guidance to the PV Science team on the day-to-day safety monitoring activities and safety data for assigned products
- Review and summarize individual case reports as well as aggregate data summaries as needed
- Provide safety science and pharmacovigilance subject matter expertise on program and study teams as well as other cross-functional platforms throughout the company
- Facilitate cross-functional Safety Review Committee meetings; includes coordinating materials, data presentation and all outputs, and agenda
- Review and provide PV Science input to all core clinical documents including protocols, IBs, ICFs, and CSRs
- Authoring of aggregate safety reports, e.g., DSURs, PSURs
- Provide subject matter expertise and input for regulatory responses and submissions
- Work with the Medical Safety team in building core PV science capabilities and processes for the department
- Degree in Pharmacy, Nursing, Epidemiology, Biosciences or equivalent healthcare degree with pharmaceutical industry background and proven competence in PV
- 15+ years’ experience in pharmaceutical industry, including 10+ years’ experience in PV
- Track record of strong personal performance combined with demonstrated ability to lead a high performing team
- Experience with working with safety vendors managing deliverables to support PV Science projects
- Experience reviewing cumulative safety data with ability to interpret, synthesize and communicate complex clinical /pharmaceutical information and safety data; oncology experience is preferred
- Experience in the preparation and authoring of pre- and post- aggregate safety reports
- Thorough understanding of the drug development process and context applicable to safety surveillance activities
- Ability to execute and follow-through to completion and documentation
- Ability to work effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view
- Independently motivated, detail oriented and good problem-solving ability
- Excellent organizational skills, sufficient to multi-task in an extremely fast-paced environment with changing priorities
- Excellent oral and written communication skills
- Ability to work and influence cross-functionally
- Solid foundation in GCP and GVP regulations
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